CompletedNot Applicable

An Observational Prospective Cohort Study Using an Actigraphy Device.

Taiwan40 participantsStarted 2018-05-15

Plain-language summary

This study focuses on whether or not physical activity and sleep quality correlate with the health of prostate and breast cancer patients. The activity data will be acquired using wearable actigraphy devices, which the subjects will wear for the duration of seven days. The sleep quality will be measured using a combination of actigraphy and the mandarin version of the Pittsburgh Sleep Quality Index (PSQI) and the Quality of Life Questionnaire (QLQ). By using this combination, the investigators will not only measure the objective physical activity while the patient is asleep, but also the subjective sleep quality. The questionnaire will also function as control data for the accuracy of the actigraphy device. This study will recruit approximately 30 breast or prostate cancer patients. The participants will wear a wearable actigraphy device for 7 consecutive days, which will provide accurate and objective movement and sleep data. This data is linked to a unique Identification number (ID), which will be noted in the participant's case report. This case report also contains the participant's information and answers to the questionnaires.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: The patient: * Is an outpatient receiving evaluation, treatment, or follow-up care at either one of the desired hospital locations in Taipei. * Has been diagnosed with prostate or breast cancer within the past year. * Is currently receiving treatment for the cancer. * Is at least 20 years old. * Is able to understand Mandarin Chinese. * Gives informed consent to participate. * scores at least 26 on the Mini-Mental State Examination (MMSE). * Has a score 45 or higher on the Berg Balance Scale test. Exclusion Criteria: The patient: * Cannot understand the intent of the study. * scores lower than 26 on the Mini-Mental State Examination (MMSE). * Is not fit to participate, as believed by their current treating physician. * Is physical unable to walk. * Has a score of \<45 on the Berg Balance Scale test. * Refuses to participate.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change will be assessed on the quality of life of breast and prostate cancer patients.

Timeframe: The time frame will be 8th day after enrolment of each respondent

Change will be assessed for the influence of physical activity on the Quality of Life of breast and prostate cancer patients.

Timeframe: The time frame will be daily for 8 days after enrolment of each respondent

Trial details

NCT IDNCT03475433

SponsorTaipei Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-07-31

View on ClinicalTrials.gov More Neoplasm of Breast (Disorder) trials